This proposal is submitted in response to an initiative of the Department of Health and Human Services to strengthen oversight of human subject research at institutions that receive substantial NIH support. This application proposes to create the foundation of an information systems infrastructure that will enable Cedars-Sinai Medical Center (CSMC) to continuously enhance the oversight of human subject research. CSMC is the largest private non-profit hospital west of the Mississippi River. There currently are more than 500 active human subject research protocols. In 2000, 53.3% of research awards at CSMC - 20.3 million dollars - were funded by federal agencies. The goal of this project is to develop an online submission, reporting, tracking, and review system that will strengthen the human subject protection program at CSMC. The Electronic Human Subject Protection Program (eHSPP) aims to: (1) strengthen the institutional education program for the safe and ethical conduct of clinical research; (2) increase the level of IRB oversight of, and monitoring for, the safe conduct of human subject research; (3) enhance the quality and efficiency of IRB reviews; and (4) improve system-wide compliance with regulations and ethical principles governing the conduct of human subject research through improved coordination between multiple institutional research review and oversight entities. The eHSPP will include online submission, tracking, and review functionality, as well as extensive educational help text and reference links. The eHSPP also will allow for robust information management and reporting capabilities. As each module of the eHSPP is brought online, as well as upon implementation of the completed eHSPP, it will be evaluated by monitoring quality and efficiency indicators as well as through the administration of pre/post user surveys. More extensive outcome evaluations and system modifications will be conducted on a continuous as needed basis subsequent to the grant period.
